JP2014515763A5 - - Google Patents
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- Publication number
- JP2014515763A5 JP2014515763A5 JP2014509377A JP2014509377A JP2014515763A5 JP 2014515763 A5 JP2014515763 A5 JP 2014515763A5 JP 2014509377 A JP2014509377 A JP 2014509377A JP 2014509377 A JP2014509377 A JP 2014509377A JP 2014515763 A5 JP2014515763 A5 JP 2014515763A5
- Authority
- JP
- Japan
- Prior art keywords
- stable liquid
- liquid pharmaceutical
- pharmaceutical formulation
- antibody
- humanized antibody
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 108090001123 antibodies Proteins 0.000 claims 25
- 102000004965 antibodies Human genes 0.000 claims 25
- 239000007788 liquid Substances 0.000 claims 22
- 239000008194 pharmaceutical composition Substances 0.000 claims 17
- 239000000203 mixture Substances 0.000 claims 10
- 238000009472 formulation Methods 0.000 claims 6
- 206010021972 Inflammatory bowel disease Diseases 0.000 claims 4
- 239000000427 antigen Substances 0.000 claims 4
- 102000038129 antigens Human genes 0.000 claims 4
- 108091007172 antigens Proteins 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 4
- 239000003963 antioxidant agent Substances 0.000 claims 3
- 239000002738 chelating agent Substances 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K 2qpq Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 2
- 239000004475 Arginine Substances 0.000 claims 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 2
- 235000001014 amino acid Nutrition 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 238000003379 elimination reaction Methods 0.000 claims 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- 230000001939 inductive effect Effects 0.000 claims 2
- 102000006495 integrins Human genes 0.000 claims 2
- 108010044426 integrins Proteins 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 238000006722 reduction reaction Methods 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- 229960002989 Glutamic Acid Drugs 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 1
- 229940068968 Polysorbate 80 Drugs 0.000 claims 1
- 230000037165 Serum Concentration Effects 0.000 claims 1
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 1
- 108010001801 Tumor Necrosis Factor-alpha Proteins 0.000 claims 1
- 235000004279 alanine Nutrition 0.000 claims 1
- 230000003042 antagnostic Effects 0.000 claims 1
- 239000005557 antagonist Substances 0.000 claims 1
- 230000000111 anti-oxidant Effects 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 239000003246 corticosteroid Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000004220 glutamic acid Substances 0.000 claims 1
- 235000013922 glutamic acid Nutrition 0.000 claims 1
- 230000002519 immonomodulatory Effects 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 239000006228 supernatant Substances 0.000 claims 1
- 229960004914 vedolizumab Drugs 0.000 claims 1
- 108010035693 vedolizumab Proteins 0.000 claims 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161481522P | 2011-05-02 | 2011-05-02 | |
| US61/481,522 | 2011-05-02 | ||
| US201161544054P | 2011-10-06 | 2011-10-06 | |
| US61/544,054 | 2011-10-06 | ||
| PCT/US2012/036069 WO2012151247A2 (fr) | 2011-05-02 | 2012-05-02 | FORMULATION POUR UN ANTICORPS ANTI-α4β7 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017094129A Division JP6467457B2 (ja) | 2011-05-02 | 2017-05-10 | 抗α４β７抗体のための製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014515763A JP2014515763A (ja) | 2014-07-03 |
| JP2014515763A5 true JP2014515763A5 (fr) | 2015-06-25 |
| JP6190359B2 JP6190359B2 (ja) | 2017-08-30 |
Family
ID=46147702
Family Applications (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014509377A Active JP6190359B2 (ja) | 2011-05-02 | 2012-05-02 | 抗α４β７抗体のための製剤 |
| JP2017094129A Active JP6467457B2 (ja) | 2011-05-02 | 2017-05-10 | 抗α４β７抗体のための製剤 |
| JP2019003265A Active JP6751450B2 (ja) | 2011-05-02 | 2019-01-11 | 抗α４β７抗体のための製剤 |
| JP2020136927A Active JP7107997B2 (ja) | 2011-05-02 | 2020-08-14 | 抗α４β７抗体のための製剤 |
| JP2022112814A Pending JP2022132430A (ja) | 2011-05-02 | 2022-07-14 | 抗α４β７抗体のための製剤 |
Family Applications After (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017094129A Active JP6467457B2 (ja) | 2011-05-02 | 2017-05-10 | 抗α４β７抗体のための製剤 |
| JP2019003265A Active JP6751450B2 (ja) | 2011-05-02 | 2019-01-11 | 抗α４β７抗体のための製剤 |
| JP2020136927A Active JP7107997B2 (ja) | 2011-05-02 | 2020-08-14 | 抗α４β７抗体のための製剤 |
| JP2022112814A Pending JP2022132430A (ja) | 2011-05-02 | 2022-07-14 | 抗α４β７抗体のための製剤 |
Country Status (37)
| Country | Link |
|---|---|
| US (6) | US10040855B2 (fr) |
| EP (3) | EP4378959A2 (fr) |
| JP (5) | JP6190359B2 (fr) |
| KR (7) | KR20230021758A (fr) |
| CN (4) | CN107998388B (fr) |
| AR (1) | AR086238A1 (fr) |
| AU (5) | AU2012250872B2 (fr) |
| CA (2) | CA2834900C (fr) |
| CL (3) | CL2013003145A1 (fr) |
| CO (1) | CO6801648A2 (fr) |
| CR (1) | CR20130556A (fr) |
| CY (1) | CY1119436T1 (fr) |
| DK (1) | DK2704742T3 (fr) |
| DO (1) | DOP2013000252A (fr) |
| EA (1) | EA032625B1 (fr) |
| EC (1) | ECSP22046340A (fr) |
| ES (1) | ES2646717T3 (fr) |
| GE (1) | GEP20186866B (fr) |
| HK (1) | HK1253911A1 (fr) |
| HR (1) | HRP20171457T1 (fr) |
| HU (1) | HUE036664T2 (fr) |
| IL (6) | IL305583A (fr) |
| LT (1) | LT2704742T (fr) |
| ME (1) | ME02858B (fr) |
| MX (4) | MX354101B (fr) |
| MY (1) | MY188820A (fr) |
| PE (1) | PE20141672A1 (fr) |
| PH (2) | PH12018502221A1 (fr) |
| PL (1) | PL2704742T3 (fr) |
| PT (1) | PT2704742T (fr) |
| RS (1) | RS56429B1 (fr) |
| SG (1) | SG194730A1 (fr) |
| SI (1) | SI2704742T1 (fr) |
| TW (5) | TWI698254B (fr) |
| UY (1) | UY34054A (fr) |
| WO (1) | WO2012151247A2 (fr) |
| ZA (2) | ZA201308168B (fr) |
Families Citing this family (47)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT3459564T (pt) | 2010-01-06 | 2022-01-31 | Takeda Pharmaceuticals Co | Proteínas de ligação à calicreína plasmática |
| SG189220A1 (en) * | 2010-10-06 | 2013-05-31 | Regeneron Pharma | Stabilized formulations containing anti-interleukin-4 receptor (il-4r) antibodies |
| KR102107695B1 (ko) | 2011-01-06 | 2020-05-07 | 다이액스 코포레이션 | 혈장 칼리크레인 결합 단백질 |
| CN107998388B (zh) | 2011-05-02 | 2023-07-14 | 千禧制药公司 | 抗α4β7抗体的制剂 |
| SG10201605516YA (en) | 2011-07-06 | 2016-08-30 | Nestec Sa | Assays for detecting neutralizing autoantibodies to biologic therapy with tnf alpha |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| US9764093B2 (en) * | 2012-11-30 | 2017-09-19 | Sio2 Medical Products, Inc. | Controlling the uniformity of PECVD deposition |
| WO2014152232A2 (fr) | 2013-03-15 | 2014-09-25 | Dyax Corp. | Anticorps anti-kallicréine plasmatique |
| KR20220129671A (ko) * | 2013-07-05 | 2022-09-23 | 인테그라 메디컬 인코포레이티드 | 구강 조성물 |
| BR112016011224A2 (pt) * | 2013-11-29 | 2017-09-19 | Ares Trading Sa | Formulação líquida de uma proteína de fusão que compreende tnfr e região de fc |
| KR20240033093A (ko) | 2014-10-06 | 2024-03-12 | 케모센트릭스, 인크. | C-c 케모카인 수용체 타입 9 (ccr9)의 억제제 및 항-알파4베타7 인테그린 차단 항체의 조합 요법 |
| US20170327584A1 (en) | 2014-11-26 | 2017-11-16 | Millennium Pharmaceuticals, Inc. | Vedolizumab for the Treatment of Fistulizing Crohn's Disease |
| US20180264111A1 (en) * | 2014-12-03 | 2018-09-20 | Csl Behring Gmbh Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
| SG11201704200SA (en) | 2014-12-05 | 2017-06-29 | Nestec Sa | Indirect homogeneous mobility shift assays for the detection of biologics in patient samples |
| JP6904905B2 (ja) | 2014-12-24 | 2021-07-21 | ミレニアム ファーマシューティカルズ， インコーポレイテッドＭｉｌｌｅｎｎｉｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | 抗α４β７インテグリン抗体による治療の結果の予測 |
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| EP3286226A4 (fr) * | 2015-03-30 | 2018-12-05 | Dyax Corp. | Inhibiteurs de la kallicréine plasmatique et utilisations desdits inhibiteurs pour prévenir un accès d'angio-oedème héréditaire |
| EA201890519A1 (ru) | 2015-08-18 | 2018-07-31 | Ридженерон Фармасьютикалз, Инк. | Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией, подвергающихся аферезу липопротеинов |
| US11286307B2 (en) | 2015-12-11 | 2022-03-29 | Takeda Pharmaceutical Company Limited | Plasma kallikrein inhibitors and uses thereof for treating hereditary angioedema attack |
| CN115400220A (zh) * | 2015-12-30 | 2022-11-29 | 豪夫迈·罗氏有限公司 | 减少聚山梨酯降解的制剂 |
| USD866757S1 (en) | 2016-03-11 | 2019-11-12 | Millennium Pharmaceuticals, Inc. | Autoinjector |
| KR102667332B1 (ko) | 2016-03-14 | 2024-05-20 | 밀레니엄 파머슈티컬스 인코퍼레이티드 | 이식편대숙주 질환을 치료하거나 예방하는 방법 |
| MA44408A (fr) * | 2016-03-14 | 2019-01-23 | Millennium Pharm Inc | Méthode de traitement de la réaction du greffon contre l'hôte (gvd) |
| EP3433275A1 (fr) | 2016-03-24 | 2019-01-30 | Millennium Pharmaceuticals, Inc. | Procédés pour traiter des événements indésirables gastro-intestinaux d'origine immunitaire dans des traitements oncologiques immunitaires |
| WO2017165742A1 (fr) | 2016-03-24 | 2017-09-28 | Millennium Pharmaceuticals, Inc. | Procédés de traitement d'événements indésirables liés à l'immunité gastro-intestinale dans des polythérapies anti-ctla4 et anti-pd-1 |
| MA44864A (fr) | 2016-05-04 | 2019-03-13 | Icahn School Med Mount Sinai | Trithérapie pour le traitement d'une maladie intestinale inflammatoire |
| CN109414502A (zh) * | 2016-06-12 | 2019-03-01 | 千禧制药公司 | 治疗炎症性肠病的方法 |
| JOP20170170B1 (ar) * | 2016-08-31 | 2022-09-15 | Omeros Corp | صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق |
| WO2018104893A1 (fr) | 2016-12-06 | 2018-06-14 | Glaxosmithkline Intellectual Property Development Limited | Anticorps anti-alpha4-beta7 présentant une liaison à fcrn et/ou une demi-vie augmentées |
| PE20191436A1 (es) * | 2016-12-23 | 2019-10-14 | Serum Institute Of India Pvt Ltd | Metodos mejorados para estimular la productividad de anticuerpos en el cultivo de celulas de mamiferos y reducir la agregacion durante los procesos de formulacion post-tratamiento (downstream) y formulaciones de anticuerpos estables obtenidas a partir de los mismos |
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| RU2020111574A (ru) * | 2017-08-25 | 2021-09-27 | Омерос Корпорейшн | Высококонцентрированные, маловязкие препараты ингибирующих masp-2 антител, наборы и способы лечения субъектов, страдающих атипическим гемолитическим синдромом |
| BR112020020707A2 (pt) * | 2018-04-10 | 2021-01-12 | Dr. Reddy's Laboratories Limited | Formulação farmacêutica estável de um anticorpo alfa4beta7 |
| SG11202009876TA (en) * | 2018-04-10 | 2020-11-27 | Dr Reddy’s Laboratories Ltd | Stable formulations of therapeutic antibody |
| SG11202009872YA (en) * | 2018-04-10 | 2020-11-27 | Dr Reddys Laboratories Ltd | Stable antibody formulation |
| EP3843783A1 (fr) * | 2018-08-29 | 2021-07-07 | GlaxoSmithKline Intellectual Property Development Limited | Procédés de préparation de compositions de protéine thérapeutique liquide stable |
| US20220142977A1 (en) * | 2019-01-08 | 2022-05-12 | Arena Pharmaceuticals, Inc. | Methods of treating conditions related to the s1p1 receptor |
| PE20212185A1 (es) | 2019-02-18 | 2021-11-11 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos |
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| WO2021070203A1 (fr) * | 2019-10-11 | 2021-04-15 | Dr. Reddy's Laboratories Limited | Formulation stable d'anticorps anti-intégrine |
| KR20230041071A (ko) * | 2020-07-31 | 2023-03-23 | 제넨테크, 인크. | 항-인테그린 베타7 항체 제제 및 장치 |
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| WO2022253994A1 (fr) * | 2021-06-04 | 2022-12-08 | Polpharma Biologics S.A. | Formulation de védolizumab |
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